FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
1993–2016 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 18, 2021
BEGO SEMADOS Tr 58350
K201412 · KCT
Bego Implant Systems GmbH & Co. KG
General Hospital · 266d
Cleared Feb 17, 2021
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling...
K202401 · KGO
Eco Medi Glove Sdn. Bhd.
General Hospital · 180d
Cleared Feb 16, 2021
EZ-Injec LDV Sterile Safety Needle
K210444 · QNS
Poonglim Pharmatech, Inc.
General Hospital
Cleared Feb 16, 2021
PLPT LDV (Low Dead Volume) Sterile Syringe
K210443 · QNQ
Poonglim Pharmatech, Inc.
General Hospital
Cleared Feb 16, 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal...
K201732 · FXX
Dukal Corporation
General Hospital · 236d
Cleared Feb 12, 2021
Vinyl Examination Gloves (Yellow)
K203702 · LYZ
Xinying Trading Co., Ltd.
General Hospital · 56d
Cleared Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
K203191 · LZA
Nathan Trading Co., Ltd.
General Hospital · 108d
Cleared Feb 12, 2021
Infrared Thermometer
K202368 · FLL
Shandong Bittel Intelligent...
General Hospital · 177d
Cleared Feb 12, 2021
Disposable Surgical Mask
K202341 · FXX
Shanghai Jianzhong Medical Packaging...
General Hospital · 179d
Cleared Feb 12, 2021
Panda iRes Warmer, Giraffe Warmer
K201628 · FMT
Ge Healthcare
General Hospital · 241d
Cleared Feb 12, 2021
Surgical Face Mask
K201545 · FXX
Amphastar Nanjing Pharmaceuticals, Inc.
General Hospital · 248d
Cleared Feb 10, 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · FXX
Jiangsu Medplus Non-Woven...
General Hospital · 155d
Cleared Feb 10, 2021
Infrared Forehead Thermometer
K201536 · FLL
Hangzhou Qingyuan Medical Equipment...
General Hospital · 247d
Cleared Feb 09, 2021
nPro Surgical Mask
K203265 · FXX
Np Medical, Inc.
General Hospital · 96d
Cleared Feb 08, 2021
HydroMID
K203069 · FOZ
Access Vascular, Inc.
General Hospital · 122d
Cleared Feb 05, 2021
Freudenberg Surgical Mask
K210063 · FXX
Freudenberg Performance Materials LP
General Hospital · 25d
Cleared Feb 05, 2021
Dukal Corporation Level 2 Surgical Mask with Ear Loops
K201421 · FXX
Dukal Corporation
General Hospital · 252d
Cleared Feb 04, 2021
Medical Face Mask
K202493 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 157d
Cleared Feb 03, 2021
Medical Face Masks
K202627 · FXX
Guilin Hbm Sanitary Protections, Inc.
General Hospital · 145d
Cleared Feb 02, 2021
Disposable Medical Surgical Mask
K202511 · FXX
Improve Medical (Hunan) Co., Ltd.
General Hospital · 155d
Cleared Feb 02, 2021
Medical Face Mask
K202331 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 169d
Cleared Feb 02, 2021
Disposable Medical Surgical Masks
K202323 · FXX
Tianjin Teda Jinshan Easy Packing...
General Hospital · 169d
Cleared Feb 02, 2021
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
K202096 · FXX
Ecoguard, Inc.
General Hospital · 188d
Cleared Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 421d